Trial Outcomes & Findings for Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects (NCT NCT02365766)
NCT ID: NCT02365766
Last Updated: 2025-03-18
Results Overview
Number of patients with experienced Dose-Limiting Toxicities (DLTs) will be monitored as a safety and tolerability of pembrolizumab in combination with gemcitabine and cisplatin . The Pembrolizumab DLT is defined as a drug-related adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) V4 criteria that occurs in the first 4 weeks of treatment of pembrolizumab (C1D8 - C2D14) and meets the DLT definition per protocol.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2025-03-18
Participant Flow
All participants in Phase 1b received same dose (Pembrolizumab 200 mg).
Participant milestones
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort I: Cisplatin-eligible- Pembrolizumab 200 mg
Arm B: Cisplatin-eligible subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days) . Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. Note: the last dose of pembrolizumab falls on what would be day 8 of a 5th 'chemo' cycle, however gemcitabine/cisplatin is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase II cohort 1, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort II: Cisplatin-ineligible -Pembrolizumab 200 mg
Arm C: Cisplatin-ineligible subjects receive gemcitabine every week every 28 days for 3 cycles. Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every 3-week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: D1 and D22. Additionally, the last dose of pembrolizumab falls on what would be D8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-ineligible patients on phase II cohort II, gemcitabine 1000mg/m2 will be administered D1, D8 and D15 every 28 days for 3 cycles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
37
|
40
|
|
Overall Study
COMPLETED
|
6
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort I: Cisplatin-eligible- Pembrolizumab 200 mg
Arm B: Cisplatin-eligible subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days) . Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. Note: the last dose of pembrolizumab falls on what would be day 8 of a 5th 'chemo' cycle, however gemcitabine/cisplatin is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase II cohort 1, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort II: Cisplatin-ineligible -Pembrolizumab 200 mg
Arm C: Cisplatin-ineligible subjects receive gemcitabine every week every 28 days for 3 cycles. Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every 3-week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: D1 and D22. Additionally, the last dose of pembrolizumab falls on what would be D8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-ineligible patients on phase II cohort II, gemcitabine 1000mg/m2 will be administered D1, D8 and D15 every 28 days for 3 cycles.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Eligibility Criteria Not Met
|
0
|
0
|
1
|
Baseline Characteristics
Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects
Baseline characteristics by cohort
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
n=6 Participants
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort I: Cisplatin-eligible- Pembrolizumab 200 mg
n=37 Participants
Arm B: Cisplatin-eligible subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days) . Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. Note: the last dose of pembrolizumab falls on what would be day 8 of a 5th 'chemo' cycle, however gemcitabine/cisplatin is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase II cohort 1, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort II: Cisplatin-ineligible -Pembrolizumab 200 mg
n=38 Participants
Arm C: Cisplatin-ineligible subjects receive gemcitabine every week every 28 days for 3 cycles. Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every 3-week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: D1 and D22. Additionally, the last dose of pembrolizumab falls on what would be D8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-ineligible patients on phase II cohort II, gemcitabine 1000mg/m2 will be administered D1, D8 and D15 every 28 days for 3 cycles.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
63 years
n=7 Participants
|
73 years
n=5 Participants
|
68 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
37 participants
n=7 Participants
|
38 participants
n=5 Participants
|
81 participants
n=4 Participants
|
|
ECOG performance status
ECOG = 0
|
6 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
ECOG performance status
ECOG = 1
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
ECOG performance status
ECOG = 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: All participants in Phase 1b received same dose.
Number of patients with experienced Dose-Limiting Toxicities (DLTs) will be monitored as a safety and tolerability of pembrolizumab in combination with gemcitabine and cisplatin . The Pembrolizumab DLT is defined as a drug-related adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) V4 criteria that occurs in the first 4 weeks of treatment of pembrolizumab (C1D8 - C2D14) and meets the DLT definition per protocol.
Outcome measures
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
n=6 Participants
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg
Cisplatin ineligible (receive treatment in Phase II only) : Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
|
|---|---|---|
|
Phase Ib: Safety of Pembrolizumab in Combination With Gemcitabine-Cisplatin
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 2-7 weeks post last dose of pembrolizumab (up to 6 months)Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint PaIR Rate was defined as all Cisplatin-eligible treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2. 38 out of 43 Cisplatin eligible patients and 33 out of 38 Cisplatin ineligible patients had data of pathological response.
Pathologic muscle invasion response (PaIR), or ≤ypT1N0M0, rate is assessed from the consolidative surgery (radical cystectomy (RC) / nephroureterectomy (NU) - lymph node dissection (LND)) specimen.
Outcome measures
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
n=38 Participants
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg
n=33 Participants
Cisplatin ineligible (receive treatment in Phase II only) : Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
|
|---|---|---|
|
Rate of Pathologic Muscle Invasive Response (PaIR)
|
61 Percentage of participants
Interval 46.0 to 74.0
|
51.5 Percentage of participants
Interval 35.0 to 68.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Relapse-Free Survival was defined as all Cisplatin-eligible patients treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible patients treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2. 37 out of 38 Cisplatin ineligible patients were evaluable for RFS.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Relapse-Free Survival is defined by the date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs.
Outcome measures
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
n=43 Participants
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg
n=37 Participants
Cisplatin ineligible (receive treatment in Phase II only) : Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
|
|---|---|---|
|
Relapse-Free Survival (RFS) at 18 Months
|
83 Percentage of participants
Interval 67.0 to 91.0
|
57.4 Percentage of participants
Interval 40.0 to 72.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall Survival was defined as all Cisplatin-eligible patients treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible patients treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2.
Determine the Overall survival at 5 years. OS is defined by the date of randomization to date of death from any cause.
Outcome measures
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
n=43 Participants
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg
n=38 Participants
Cisplatin ineligible (receive treatment in Phase II only) : Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
|
|---|---|---|
|
Overall Survival (OS) at 5 Years
|
71.9 Percentage of participants
Interval 55.0 to 83.0
|
56.6 Percentage of participants
Interval 39.0 to 71.0
|
SECONDARY outcome
Timeframe: Within 2-7 weeks post last dose of pembrolizumab (up to 6 months)Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Radical Cystectomy Rate was defined as all Cisplatin-eligible patients treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible patients treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2. 37 out of 38 Cisplatin ineligible patients were evaluable for Radical Cystectomy Rate.
To compare the radical cystectomy (RC) rates in subjects who are cisplatin-eligible with those who are cisplatin-ineligible.
Outcome measures
| Measure |
Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg
n=43 Participants
Arm A: Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg
n=37 Participants
Cisplatin ineligible (receive treatment in Phase II only) : Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
|
|---|---|---|
|
Radical Cystectomy (RC) Rate
|
86 Percentage of participants
Interval 73.0 to 93.0
|
89 Percentage of participants
Interval 76.0 to 96.0
|
Adverse Events
Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg
Serious events: 17 serious events
Other events: 37 other events
Deaths: 11 deaths
Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg
Serious events: 17 serious events
Other events: 38 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg
n=6 participants at risk
Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg
n=37 participants at risk
Cisplatin-eligible subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days) . Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. Note: the last dose of pembrolizumab falls on what would be day 8 of a 5th 'chemo' cycle, however gemcitabine/cisplatin is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase II cohort 1, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg
n=38 participants at risk
Cisplatin ineligible (receive treatment in Phase II only): Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
ACIDOSIS
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
16.7%
1/6 • Number of events 2 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
General disorders
FEVER
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Infections and infestations
SEPSIS
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Investigations
CREATININE INCREASED
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 3 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
JEJUNAL FISTULA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Cardiac disorders
MOBITZ TYPE I
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 4 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Nervous system disorders
DYSPHASIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Cardiac disorders
HEART FAILURE
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
General disorders
PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
Other adverse events
| Measure |
Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg
n=6 participants at risk
Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg
n=37 participants at risk
Cisplatin-eligible subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days) . Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. Note: the last dose of pembrolizumab falls on what would be day 8 of a 5th 'chemo' cycle, however gemcitabine/cisplatin is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Pembrolizumab: Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase II cohort 1, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
|
Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg
n=38 participants at risk
Cisplatin ineligible (receive treatment in Phase II only): Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
13.2%
5/38 • Number of events 9 • Up to a maximum of 5 years
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
33.3%
2/6 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 5 • Up to a maximum of 5 years
|
28.9%
11/38 • Number of events 24 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
50.0%
3/6 • Number of events 3 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
2/6 • Number of events 2 • Up to a maximum of 5 years
|
37.8%
14/37 • Number of events 17 • Up to a maximum of 5 years
|
15.8%
6/38 • Number of events 7 • Up to a maximum of 5 years
|
|
Blood and lymphatic system disorders
ANEMIA
|
83.3%
5/6 • Number of events 14 • Up to a maximum of 5 years
|
62.2%
23/37 • Number of events 97 • Up to a maximum of 5 years
|
81.6%
31/38 • Number of events 112 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
50.0%
3/6 • Number of events 5 • Up to a maximum of 5 years
|
43.2%
16/37 • Number of events 27 • Up to a maximum of 5 years
|
50.0%
19/38 • Number of events 32 • Up to a maximum of 5 years
|
|
Psychiatric disorders
ANXIETY
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 5 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
1/6 • Number of events 2 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 4 • Up to a maximum of 5 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
16.7%
1/6 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
31.6%
12/38 • Number of events 20 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 9 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
BLOATING
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Eye disorders
BLURRED VISION
|
50.0%
3/6 • Number of events 4 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Injury, poisoning and procedural complications
BRUISING
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
3/6 • Number of events 7 • Up to a maximum of 5 years
|
51.4%
19/37 • Number of events 29 • Up to a maximum of 5 years
|
52.6%
20/38 • Number of events 28 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
2/6 • Number of events 2 • Up to a maximum of 5 years
|
24.3%
9/37 • Number of events 10 • Up to a maximum of 5 years
|
42.1%
16/38 • Number of events 18 • Up to a maximum of 5 years
|
|
Investigations
CREATININE INCREASED
|
33.3%
2/6 • Number of events 3 • Up to a maximum of 5 years
|
21.6%
8/37 • Number of events 18 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 12 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
13.2%
5/38 • Number of events 6 • Up to a maximum of 5 years
|
|
Psychiatric disorders
DEPRESSION
|
33.3%
2/6 • Number of events 2 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
DIARRHEA
|
50.0%
3/6 • Number of events 5 • Up to a maximum of 5 years
|
18.9%
7/37 • Number of events 9 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 13 • Up to a maximum of 5 years
|
|
Nervous system disorders
DIZZINESS
|
50.0%
3/6 • Number of events 6 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 8 • Up to a maximum of 5 years
|
|
Nervous system disorders
DYSGEUSIA
|
33.3%
2/6 • Number of events 2 • Up to a maximum of 5 years
|
27.0%
10/37 • Number of events 10 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
66.7%
4/6 • Number of events 7 • Up to a maximum of 5 years
|
24.3%
9/37 • Number of events 9 • Up to a maximum of 5 years
|
47.4%
18/38 • Number of events 34 • Up to a maximum of 5 years
|
|
General disorders
EDEMA LIMBS
|
33.3%
2/6 • Number of events 3 • Up to a maximum of 5 years
|
24.3%
9/37 • Number of events 9 • Up to a maximum of 5 years
|
44.7%
17/38 • Number of events 23 • Up to a maximum of 5 years
|
|
General disorders
FATIGUE
|
83.3%
5/6 • Number of events 13 • Up to a maximum of 5 years
|
81.1%
30/37 • Number of events 50 • Up to a maximum of 5 years
|
76.3%
29/38 • Number of events 48 • Up to a maximum of 5 years
|
|
General disorders
FEVER
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
26.3%
10/38 • Number of events 13 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
33.3%
2/6 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 9 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
50.0%
3/6 • Number of events 3 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
15.8%
6/38 • Number of events 6 • Up to a maximum of 5 years
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
33.3%
2/6 • Number of events 6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 9 • Up to a maximum of 5 years
|
18.4%
7/38 • Number of events 14 • Up to a maximum of 5 years
|
|
Vascular disorders
HYPERTENSION
|
66.7%
4/6 • Number of events 9 • Up to a maximum of 5 years
|
35.1%
13/37 • Number of events 25 • Up to a maximum of 5 years
|
47.4%
18/38 • Number of events 37 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
50.0%
3/6 • Number of events 6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 3 • Up to a maximum of 5 years
|
26.3%
10/38 • Number of events 19 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
50.0%
3/6 • Number of events 4 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 6 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
33.3%
2/6 • Number of events 2 • Up to a maximum of 5 years
|
18.9%
7/37 • Number of events 8 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 13 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
16.7%
1/6 • Number of events 4 • Up to a maximum of 5 years
|
18.9%
7/37 • Number of events 10 • Up to a maximum of 5 years
|
15.8%
6/38 • Number of events 11 • Up to a maximum of 5 years
|
|
Vascular disorders
HYPOTENSION
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Psychiatric disorders
INSOMNIA
|
50.0%
3/6 • Number of events 3 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
16.7%
1/6 • Number of events 3 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 10 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 24 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY
|
50.0%
3/6 • Number of events 7 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
6/6 • Number of events 10 • Up to a maximum of 5 years
|
56.8%
21/37 • Number of events 40 • Up to a maximum of 5 years
|
44.7%
17/38 • Number of events 27 • Up to a maximum of 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
50.0%
3/6 • Number of events 7 • Up to a maximum of 5 years
|
48.6%
18/37 • Number of events 32 • Up to a maximum of 5 years
|
34.2%
13/38 • Number of events 26 • Up to a maximum of 5 years
|
|
General disorders
PAIN
|
50.0%
3/6 • Number of events 3 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 9 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 13 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
16.7%
1/6 • Number of events 3 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
50.0%
3/6 • Number of events 7 • Up to a maximum of 5 years
|
24.3%
9/37 • Number of events 11 • Up to a maximum of 5 years
|
15.8%
6/38 • Number of events 7 • Up to a maximum of 5 years
|
|
Investigations
PLATELET COUNT DECREASED
|
33.3%
2/6 • Number of events 4 • Up to a maximum of 5 years
|
40.5%
15/37 • Number of events 36 • Up to a maximum of 5 years
|
44.7%
17/38 • Number of events 39 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.7%
1/6 • Number of events 3 • Up to a maximum of 5 years
|
21.6%
8/37 • Number of events 10 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 9 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
50.0%
3/6 • Number of events 5 • Up to a maximum of 5 years
|
29.7%
11/37 • Number of events 14 • Up to a maximum of 5 years
|
18.4%
7/38 • Number of events 9 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 4 • Up to a maximum of 5 years
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 6 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 3 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 6 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 10 • Up to a maximum of 5 years
|
|
Infections and infestations
SKIN INFECTION
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Ear and labyrinth disorders
TINNITUS
|
50.0%
3/6 • Number of events 5 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 7 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Nervous system disorders
TREMOR
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
33.3%
2/6 • Number of events 3 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
33.3%
2/6 • Number of events 3 • Up to a maximum of 5 years
|
24.3%
9/37 • Number of events 13 • Up to a maximum of 5 years
|
31.6%
12/38 • Number of events 13 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
16.7%
1/6 • Number of events 1 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 5 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
2/6 • Number of events 3 • Up to a maximum of 5 years
|
29.7%
11/37 • Number of events 14 • Up to a maximum of 5 years
|
21.1%
8/38 • Number of events 11 • Up to a maximum of 5 years
|
|
Investigations
WEIGHT LOSS
|
50.0%
3/6 • Number of events 4 • Up to a maximum of 5 years
|
21.6%
8/37 • Number of events 11 • Up to a maximum of 5 years
|
10.5%
4/38 • Number of events 4 • Up to a maximum of 5 years
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
50.0%
3/6 • Number of events 7 • Up to a maximum of 5 years
|
18.9%
7/37 • Number of events 16 • Up to a maximum of 5 years
|
23.7%
9/38 • Number of events 24 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
18.4%
7/38 • Number of events 8 • Up to a maximum of 5 years
|
|
Infections and infestations
BLADDER INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Infections and infestations
BRONCHIAL INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Eye disorders
CATARACT
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Investigations
CHOLESTEROL HIGH
|
0.00%
0/6 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Eye disorders
DRY EYE
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 4 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
General disorders
EDEMA FACE
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Eye disorders
EYE PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Vascular disorders
FLUSHING
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
0.00%
0/6 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • Up to a maximum of 5 years
|
16.2%
6/37 • Number of events 6 • Up to a maximum of 5 years
|
28.9%
11/38 • Number of events 15 • Up to a maximum of 5 years
|
|
Vascular disorders
HEMATOMA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
15.8%
6/38 • Number of events 8 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/6 • Up to a maximum of 5 years
|
16.2%
6/37 • Number of events 7 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Vascular disorders
HOT FLASHES
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
10.5%
4/38 • Number of events 9 • Up to a maximum of 5 years
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 4 • Up to a maximum of 5 years
|
13.2%
5/38 • Number of events 12 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
ILEAL OBSTRUCTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 6 • Up to a maximum of 5 years
|
26.3%
10/38 • Number of events 15 • Up to a maximum of 5 years
|
|
General disorders
INFUSION RELATED REACTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Injury, poisoning and procedural complications
INJURY TO SUPERIOR VENA CAVA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
General disorders
LOCALIZED EDEMA
|
0.00%
0/6 • Up to a maximum of 5 years
|
8.1%
3/37 • Number of events 3 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
10.5%
4/38 • Number of events 7 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 4 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/6 • Up to a maximum of 5 years
|
18.9%
7/37 • Number of events 9 • Up to a maximum of 5 years
|
18.4%
7/38 • Number of events 8 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Injury, poisoning and procedural complications
PANCREATIC ANASTOMOTIC LEAK
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
10.8%
4/37 • Number of events 5 • Up to a maximum of 5 years
|
10.5%
4/38 • Number of events 7 • Up to a maximum of 5 years
|
|
Reproductive system and breast disorders
PENILE PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
0.00%
0/6 • Up to a maximum of 5 years
|
24.3%
9/37 • Number of events 12 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
RHINITIS INFECTIVE
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 2 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Vascular disorders
SUPERFICIAL THROMBOPHLEBITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
0.00%
0/6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 5 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 3 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
13.5%
5/37 • Number of events 6 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
URINARY URGENCY
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
0.00%
0/38 • Up to a maximum of 5 years
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
2.7%
1/37 • Number of events 1 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Eye disorders
WATERING EYES
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Investigations
WEIGHT GAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
5.4%
2/37 • Number of events 2 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Nervous system disorders
AKATHISIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
General disorders
CHILLS
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
10.5%
4/38 • Number of events 4 • Up to a maximum of 5 years
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Ear and labyrinth disorders
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Cardiac disorders
HEART FAILURE
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
7.9%
3/38 • Number of events 4 • Up to a maximum of 5 years
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Vascular disorders
LYMPHEDEMA
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
General disorders
MALAISE
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Infections and infestations
MUCOSAL INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLORATION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 3 • Up to a maximum of 5 years
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL MUCOSITIS
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
5.3%
2/38 • Number of events 2 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
SCROTAL INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Reproductive system and breast disorders
VAGINAL PAIN
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/6 • Up to a maximum of 5 years
|
0.00%
0/37 • Up to a maximum of 5 years
|
2.6%
1/38 • Number of events 1 • Up to a maximum of 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place