Trial Outcomes & Findings for A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Adults With Stage III Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02412371)
NCT ID: NCT02412371
Last Updated: 2020-07-22
Results Overview
DLTs were defined as the following events considered treatment-related by the Investigator, graded per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. * Radiation-induced myelopathy/myelitis or ≥ Grade (G) 3 cardiac toxicity * Radiation-related pneumonitis resulting in delay in RT, CT, or veliparib of \>3 weeks or early discontinuation (DC) of RT (total dose \<50 Gy) * ≥G4 esophagitis or esophagitis, dysphagia, and odynophagia requiring treatment interruption of \>7 days despite medical management, neutropenia for \>7 days or neutropenic fever or thrombocytopenia * ≥G2 seizure * G4 diarrhea or nausea/vomiting despite antiemetic therapy for \>48 hours * Any other toxicity resulting in delay in RT, CT or veliparib \>14 days or early DC of RT * Other nonhematologic toxicities ≥G3, except anorexia, fatigue, G3 infection, G3 aspartate/alanine transferase (AST/ALT) elevations ≤7 days, infusion reactions, G3/4 lymphopenia or electrolyte abnormalities corrected to ≤G2 in \<48 hours
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
For Cohorts 1 - 5, from the start of veliparib dosing through 28 days after RT completion or until initiation of consolidation CT, approx. 10 weeks; For Cohort 6, 21 days from start of consolidation CT or until the start of cycle 2 consolidation therapy.
Results posted on
2020-07-22
Participant Flow
This study enrolled 48 participants at 10 sites in the United States. The study was designed as a 2-phase study consisting of a Phase 1, dose escalation of veliparib in combination with concurrent chemoradiotherapy (CRT) and consolidation chemotherapy (CT) and a Phase 2, randomized, double-blinded study.
Participants in Phase 1 were sequentially assigned to ascending dose levels of veliparib in combination with carboplatin/paclitaxel chemoradiotherapy. Phase 2 was not conducted since there was a change in standard of care for newly diagnosed, unresectable Stage III non-small cell lung cancer (NSCLC). Results are reported for Phase 1.
Participant milestones
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 60 mg veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy (RT) for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
7
|
8
|
12
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
7
|
8
|
12
|
5
|
Reasons for withdrawal
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 60 mg veliparib twice daily (BID) in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy (RT) for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
1
|
0
|
|
Overall Study
Sponsor Discontinued Study
|
1
|
4
|
6
|
4
|
5
|
0
|
|
Overall Study
Death
|
4
|
2
|
1
|
3
|
5
|
2
|
|
Overall Study
Other
|
2
|
1
|
0
|
0
|
1
|
3
|
Baseline Characteristics
A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Adults With Stage III Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 Participants
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
n=9 Participants
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 Participants
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
n=8 Participants
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
n=12 Participants
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
n=5 Participants
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 6.39 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 7.55 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 6.07 • n=4 Participants
|
67.3 years
STANDARD_DEVIATION 9.39 • n=21 Participants
|
65.6 years
STANDARD_DEVIATION 11.84 • n=8 Participants
|
65.8 years
STANDARD_DEVIATION 8.60 • n=8 Participants
|
|
Age, Customized
40 - < 60 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Age, Customized
≥ 60 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
Grade 0 (Fully active)
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
Grade 1 (Restricted but ambulatory)
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: For Cohorts 1 - 5, from the start of veliparib dosing through 28 days after RT completion or until initiation of consolidation CT, approx. 10 weeks; For Cohort 6, 21 days from start of consolidation CT or until the start of cycle 2 consolidation therapy.Population: Participants who received at least 1 dose of veliparib
DLTs were defined as the following events considered treatment-related by the Investigator, graded per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. * Radiation-induced myelopathy/myelitis or ≥ Grade (G) 3 cardiac toxicity * Radiation-related pneumonitis resulting in delay in RT, CT, or veliparib of \>3 weeks or early discontinuation (DC) of RT (total dose \<50 Gy) * ≥G4 esophagitis or esophagitis, dysphagia, and odynophagia requiring treatment interruption of \>7 days despite medical management, neutropenia for \>7 days or neutropenic fever or thrombocytopenia * ≥G2 seizure * G4 diarrhea or nausea/vomiting despite antiemetic therapy for \>48 hours * Any other toxicity resulting in delay in RT, CT or veliparib \>14 days or early DC of RT * Other nonhematologic toxicities ≥G3, except anorexia, fatigue, G3 infection, G3 aspartate/alanine transferase (AST/ALT) elevations ≤7 days, infusion reactions, G3/4 lymphopenia or electrolyte abnormalities corrected to ≤G2 in \<48 hours
Outcome measures
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 Participants
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
n=9 Participants
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 Participants
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
n=8 Participants
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
n=12 Participants
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
n=5 Participants
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Tumor assessments were performed prior to consolidation chemotherapy, 24 weeks after start of treatment, every 8 weeks until 1 year after start of treatment, and then every 12 weeks until disease progression; median time on follow-up was 11 months.Population: Participants who received at least 1 dose of veliparib and with at least one post-baseline tumor assessment
Objective response rate (ORR) is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1. Participants who did not meet complete response or partial response, including those who did not have post-baseline radiological assessments were considered as non-responders. Complete Response (CR): The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response must have been confirmed 4 weeks after the first documentation.
Outcome measures
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=6 Participants
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
n=8 Participants
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 Participants
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
n=8 Participants
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
n=11 Participants
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
n=3 Participants
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
72.7 percentage of participants
Interval 39.0 to 94.0
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
POST_HOC outcome
Timeframe: From first dose until end of study; maximum time on follow-up was approximately 46 months.Population: All participants who received veliparib; PFS was pre-specified in the Protocol as a primary endpoint in Phase 2, which was not conducted. For Phase 1 PFS was not a pre-specified endpoint, and was only analyzed for all treatment cohorts combined due to the small sample sizes within each cohort.
Progression-free survival (PFS) was defined as the time from first dose of study drug to the date of earliest radiographic disease progression per investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, and was calculated using Kaplan-Meier methods. All radiographic disease progression was included regardless whether the event occurred while the participant was taking study drug or had previously discontinued study drug. Participants who did not experience radiographic disease progression or death were censored at the date of the last disease assessment. Participants with no post-baseline disease assessment were censored at first dose date plus 1 day. Progressive disease (PD) was defined as at least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=48 Participants
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
19.6 months
Interval 9.7 to 32.6
|
—
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: From first dose of study drug until end of study; maximum time on follow-up was approximately 46 months.Population: All participants who received veliparib; OS was pre-specified in the Protocol as a secondary endpoint in Phase 2, which was not conducted. For Phase 1 OS was not a pre-specified endpoint, and was only analyzed for all treatment cohorts combined due to the small sample sizes within each cohort.
Overall survival (OS) was defined as the time from the participant's first dose of study drug to the date of death, and was calculated using Kaplan-Meier methods. Participants who did not die were censored at the date of last study visit or the last known date to be alive, whichever was later.
Outcome measures
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=48 Participants
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
32.6 months
Interval 15.0 to
Could not be calculated due to the low number of events
|
—
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Tumor assessments were performed prior to consolidation chemotherapy, 24 weeks after start of treatment, every 8 weeks until 1 year after start of treatment, and then every 12 weeks until disease progression; median time on follow-up was 11 months.Population: Participants who received at least 1 dose of veliparib with at least 1 post-baseline tumor assessment and a confirmed response; DOR was prespecified as a secondary endpoint in Phase 2, which was not conducted. For Phase 1 DOR was not a prespecified endpoint and was only analyzed for all cohorts combined due to the small sample size of each cohort.
Duration of overall response was defined as time from the date of first response (CR or PR) to the earliest documentation of radiographic progressive disease or death due to disease progression, calculated using Kaplan-Meier methods. Participants who did not experience radiographic disease progression or death were censored at the date of the last disease assessment.
Outcome measures
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=27 Participants
Participants received 60 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Duration of Overall Response (DOR)
|
30.4 months
Interval 17.5 to
Could not be estimated due to the low number of events
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
Serious events: 2 serious events
Other events: 7 other events
Deaths: 5 deaths
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
Serious events: 5 serious events
Other events: 9 other events
Deaths: 3 deaths
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
Serious events: 3 serious events
Other events: 8 other events
Deaths: 3 deaths
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
Serious events: 3 serious events
Other events: 12 other events
Deaths: 6 deaths
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 participants at risk
Participants received 60 mg veliparib BID in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
n=9 participants at risk
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 participants at risk
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
n=8 participants at risk
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
n=12 participants at risk
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
n=5 participants at risk
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
OESOPHAGEAL OBSTRUCTION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
VOMITING
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
PYREXIA
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
RADIATION PNEUMONITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
Other adverse events
| Measure |
Veliparib 60 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 participants at risk
Participants received 60 mg veliparib BID in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 80 mg BID + CRT -> Veliparib 120 mg BID + CT
n=9 participants at risk
Participants received 80 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 120 mg BID + CRT -> Veliparib 120 mg BID + CT
n=7 participants at risk
Participants received 120 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 200 mg BID + CRT -> Veliparib 120 mg BID + CT
n=8 participants at risk
Participants received 200 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 120 mg BID + CT
n=12 participants at risk
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 120 mg BID with carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
Veliparib 240 mg BID + CRT -> Veliparib 240 mg BID + CT
n=5 participants at risk
Participants received 240 mg veliparib BID in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks.
After completion of concurrent CRT participants received up to 2 cycles of consolidation therapy consisting of veliparib 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
42.9%
3/7 • Number of events 9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
3/9 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
42.9%
3/7 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
50.0%
6/12 • Number of events 11 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
60.0%
3/5 • Number of events 10 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
44.4%
4/9 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
42.9%
3/7 • Number of events 12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
58.3%
7/12 • Number of events 16 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
80.0%
4/5 • Number of events 9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
14.3%
1/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
37.5%
3/8 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
41.7%
5/12 • Number of events 17 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
42.9%
3/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
66.7%
6/9 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
85.7%
6/7 • Number of events 12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
50.0%
4/8 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
75.0%
9/12 • Number of events 15 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
80.0%
4/5 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
66.7%
6/9 • Number of events 8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
42.9%
3/7 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
37.5%
3/8 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
75.0%
9/12 • Number of events 18 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
80.0%
4/5 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
ANGINA PECTORIS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Ear and labyrinth disorders
EXTERNAL EAR PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Ear and labyrinth disorders
TINNITUS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Eye disorders
DRY EYE
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Eye disorders
VISION BLURRED
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Eye disorders
VITREOUS FLOATERS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
57.1%
4/7 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
50.0%
4/8 • Number of events 9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
80.0%
4/5 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
DIARRHOEA
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
4/12 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
71.4%
5/7 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
87.5%
7/8 • Number of events 12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
NAUSEA
|
42.9%
3/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
55.6%
5/9 • Number of events 8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
71.4%
5/7 • Number of events 10 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
50.0%
4/8 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
83.3%
10/12 • Number of events 16 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
100.0%
5/5 • Number of events 9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
OESOPHAGEAL PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
66.7%
6/9 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
57.1%
4/7 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
50.0%
4/8 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
75.0%
9/12 • Number of events 10 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Gastrointestinal disorders
VOMITING
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
44.4%
4/9 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
4/12 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
60.0%
3/5 • Number of events 8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
ASTHENIA
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
CATHETER SITE PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
CHEST PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
CHILLS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
EXTRAVASATION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
FATIGUE
|
85.7%
6/7 • Number of events 9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
66.7%
6/9 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
71.4%
5/7 • Number of events 8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
37.5%
3/8 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
58.3%
7/12 • Number of events 11 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
100.0%
5/5 • Number of events 7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
FEELING HOT
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
GRAVITATIONAL OEDEMA
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
LOCALISED OEDEMA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
MALAISE
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
MEDICAL DEVICE SITE ERYTHEMA
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
MUCOSAL DRYNESS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
3/12 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
PYREXIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
General disorders
SWELLING FACE
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
CANDIDA INFECTION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
CATHETER SITE CELLULITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
FUNGAL INFECTION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
HERPES SIMPLEX OESOPHAGITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
INCISION SITE COMPLICATION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
RADIATION INJURY
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
RADIATION OESOPHAGITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
RADIATION PNEUMONITIS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Injury, poisoning and procedural complications
RADIATION SKIN INJURY
|
28.6%
2/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Investigations
WEIGHT DECREASED
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
42.9%
3/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
37.5%
3/8 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
41.7%
5/12 • Number of events 11 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
80.0%
4/5 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
55.6%
5/9 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
57.1%
4/7 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
41.7%
5/12 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
4/12 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Metabolism and nutrition disorders
LACTIC ACIDOSIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN BREAST NEOPLASM
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
DIZZINESS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
37.5%
3/8 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
4/12 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
HEADACHE
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
22.2%
2/9 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
42.9%
3/7 • Number of events 6 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
50.0%
4/8 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
NEURALGIA
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
28.6%
2/7 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
TASTE DISORDER
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Psychiatric disorders
ANXIETY
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Psychiatric disorders
INSOMNIA
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Psychiatric disorders
NERVOUSNESS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Reproductive system and breast disorders
VULVOVAGINAL RASH
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
71.4%
5/7 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
3/12 • Number of events 4 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
37.5%
3/8 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
37.5%
3/8 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 3 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
RASH
|
28.6%
2/7 • Number of events 5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/7 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/9 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/12 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
|
Vascular disorders
HYPOTENSION
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/8 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
0.00%
0/5 • Adverse events were collected from the first dose of study drug to 30 days after the last dose of study drug; maximum duration of treatment was 14 weeks. Deaths were collected from the first dose of study drug through the end of study, up to 46 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER