Trial Outcomes & Findings for Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074) (NCT NCT00642954)
NCT ID: NCT00642954
Last Updated: 2020-11-18
Results Overview
DLTs consisted of hematologic or non-hemtologic toxicities. Hematologic DLT was any grade (gr) 4 neutropenia lasting ≥7 days, gr 4 thrombocytopenia or gr 5 hematologic toxicity. Non-hematologic DLT was any gr 3, 4 or 5 non-hematologic toxicity with the exception of (1) gr 3 nausea, vomiting, diarrhea or dehydration not compliant with medical care, lasting \<48 hours (2) gr 3 acidosis/alkalosis returning to ≤ gr 2 by 48 hours of medical care (3) gr 3 liver function test elevation without symptoms, lasting ≤5 days (4) Gr 3 amylase elevation without symptoms (5) Gr 3 hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia or hyphosphatemia responding to medical care (6) Gr 3 hypercholeresterolemia or hypertriglyceridemia. A drug-related AE causing dose modification of study drug is also considered a DLT. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants who got ≥1 dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Cycle 1 (Up to 28 days)
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
3
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
3
|
16
|
Reasons for withdrawal
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
3
|
3
|
3
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
6
|
Baseline Characteristics
Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)
Baseline characteristics by cohort
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
n=17 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.5 Years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
58.5 Years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
66.3 Years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
55.7 Years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
64.1 Years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
63.5 Years
STANDARD_DEVIATION 7.0 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Up to 28 days)Population: All participants who received ≥1 dose of study treatment.
DLTs consisted of hematologic or non-hemtologic toxicities. Hematologic DLT was any grade (gr) 4 neutropenia lasting ≥7 days, gr 4 thrombocytopenia or gr 5 hematologic toxicity. Non-hematologic DLT was any gr 3, 4 or 5 non-hematologic toxicity with the exception of (1) gr 3 nausea, vomiting, diarrhea or dehydration not compliant with medical care, lasting \<48 hours (2) gr 3 acidosis/alkalosis returning to ≤ gr 2 by 48 hours of medical care (3) gr 3 liver function test elevation without symptoms, lasting ≤5 days (4) Gr 3 amylase elevation without symptoms (5) Gr 3 hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia or hyphosphatemia responding to medical care (6) Gr 3 hypercholeresterolemia or hypertriglyceridemia. A drug-related AE causing dose modification of study drug is also considered a DLT. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants who got ≥1 dose of study drug.
Outcome measures
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
n=17 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)Population: All participants who received ≥1 dose of study treatment.
An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. An AE was considered related to a drug as determined by the investigator based on exposure (evidence of exposure to drug), time course (time of AE onset versus drug-induced effect), likely cause (AE etiology related or un-related to drug), de-challenge (drug dose reduction/discontinuation) or re-challenge (drug re-exposure). Per protocol participants experiencing drug-related AEs were analyzed at the time of the protocol-specified final statistical analysis with a 3-September (Sep)-2012 data cut-off. The number of participants experiencing drug-related AEs is reported here for all participants who got ≥1 dose of study drug.
Outcome measures
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
n=17 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Drug-Related Adverse Events (AEs)
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)Population: All participants who received ≥1 dose of study treatment and had a post baseline efficacy assessment.
Best overall tumor response consisted of CR (negative M-protein immunofixation \[IF\], \<5% bone marrow \[BM\] plasma cells, no soft tissue plasmacytomas \[STP\]), NCR (positive M-protein IF, \<5% BM plasma cells, no STP), VGPR (≥90% M-protein decrease, \<5% BM plasma cells, no STP), PR (≥50% M-protein, BM plasma cells, STP decrease), MR (25-49% M-protein, BM plasma cells, STP decrease), SD (\<25% decrease-25% increase in M-protein, BM plasma cells; \<25% decrease-increase in definite STP) or PD (≥25% M-protein, BM plasma cells increase; new STP, lesions). Per protocol participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD were analyzed as a single prespecified analysis at the time of protocol-specified final statistical analysis with a 3-Sep-2012 data cut-off. The number of participants experiencing best overall response by CR, NCR, VGPR, PR, MR, SD or PD is reported here for all participants who got ≥1 dose of study drug and had a post baseline efficacy assessment.
Outcome measures
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
n=4 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
n=3 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
n=16 Participants
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
NCR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
VGPR
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
PR
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
MR
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
SD
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants Experiencing Best Overall Response Determined by Complete Response (CR), Near Complete Response (NCR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
PD
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
Serious events: 8 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
n=4 participants at risk
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
n=4 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
n=3 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
n=3 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
n=17 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bronchitis viral
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
n=4 participants at risk
Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
n=4 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
n=3 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
n=3 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
|
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
n=17 participants at risk
Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Hypoaesthesia teeth
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
4/4 • Number of events 11 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 8 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
100.0%
3/3 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
52.9%
9/17 • Number of events 28 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 10 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 9 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • Number of events 7 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 8 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 11 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.3%
6/17 • Number of events 37 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
2/4 • Number of events 9 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 8 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
70.6%
12/17 • Number of events 70 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Angina pectoris
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.3%
6/17 • Number of events 7 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
75.0%
3/4 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
41.2%
7/17 • Number of events 20 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.3%
6/17 • Number of events 14 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.4%
5/17 • Number of events 10 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chills
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Cyst
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
64.7%
11/17 • Number of events 60 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Feeling jittery
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Local swelling
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Mass
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Medical device complication
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 6 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Herpes zoster
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.4%
5/17 • Number of events 7 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Bone fragmentation
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 9 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 9 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood calcium decreased
|
50.0%
2/4 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood calcium increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.4%
5/17 • Number of events 23 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood magnesium decreased
|
75.0%
3/4 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood phosphorus decreased
|
25.0%
1/4 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
75.0%
3/4 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 9 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood uric acid increased
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 8 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 23 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 9 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
2/4 • Number of events 6 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 11 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
100.0%
3/3 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.4%
5/17 • Number of events 7 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
41.2%
7/17 • Number of events 13 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 11 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 5 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 20 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 6 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.4%
5/17 • Number of events 6 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 16 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Sciatica
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Agitation
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Mood altered
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure acute
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Number of events 4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
41.2%
7/17 • Number of events 9 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.4%
5/17 • Number of events 15 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.4%
5/17 • Number of events 7 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
50.0%
2/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.6%
3/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.5%
4/17 • Number of events 7 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
2/17 • Number of events 3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
1/17 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 2 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Thrombophlebitis superficial
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Thrombosis
|
25.0%
1/4 • Number of events 1 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/17 • Up to ~66 months (through database cut-off date of 20-August-2013)
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER