Trial Outcomes & Findings for Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II) (NCT NCT00900627)
NCT ID: NCT00900627
Last Updated: 2016-01-20
Results Overview
DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval \> 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
330 participants
Primary outcome timeframe
Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant
Results posted on
2016-01-20
Participant Flow
Phase I: 20 patients enrolled, 6 to AZD8931 160mg, 2 to AZD8931 120 mg, 6 to AZD8931 80 mg and 6 to AZD8931 40mg. Phase II: 305 enrolled, 190 randomised, 94 and 96 allocated to AZD8931 40mg + Paclitaxel and Placebo + Paclitaxel respectively. Enrolled patients differs slightly from protocol as focus was on achieving number to be randomised.
Participant milestones
| Measure |
AZD8931 160 mg bd
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 120 mg bd
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40MG bd + Paclitaxel
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
Placebo + Paclitaxel
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
6
|
94
|
96
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
65
|
70
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
6
|
6
|
29
|
26
|
Reasons for withdrawal
| Measure |
AZD8931 160 mg bd
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 120 mg bd
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40MG bd + Paclitaxel
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
Placebo + Paclitaxel
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
Condition under investigation worsened
|
4
|
0
|
5
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
3
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
28
|
24
|
Baseline Characteristics
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
Baseline characteristics by cohort
| Measure |
AZD8931 160 mg bd
n=6 Participants
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 120 mg bd
n=2 Participants
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 80 mg bd
n=6 Participants
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40 mg bd
n=6 Participants
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40MG bd + Paclitaxel
n=94 Participants
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
Placebo + Paclitaxel
n=96 Participants
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age for Part A
|
52.7 Years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
62.0 Years
STANDARD_DEVIATION 16.97 • n=7 Participants
|
47.2 Years
STANDARD_DEVIATION 5.85 • n=5 Participants
|
54.8 Years
STANDARD_DEVIATION 11.07 • n=4 Participants
|
NA Years
STANDARD_DEVIATION NA • n=21 Participants
|
NA Years
STANDARD_DEVIATION NA • n=8 Participants
|
52.6 Years
STANDARD_DEVIATION 10.63 • n=8 Participants
|
|
Age, Continuous
Age for Part B
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=7 Participants
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=4 Participants
|
54.5 Years
STANDARD_DEVIATION 11.87 • n=21 Participants
|
53.1 Years
STANDARD_DEVIATION 10.64 • n=8 Participants
|
53.8 Years
STANDARD_DEVIATION 11.26 • n=8 Participants
|
|
Age, Customized
< = 65 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
84 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Age, Customized
> 65 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Age, Customized
18 - <50 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Age, Customized
50 - <=65 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Age, Customized
>65 - <75 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Age, Customized
>= 75 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
96 Participants
n=8 Participants
|
206 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: Native Haiwaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
74 Participants
n=8 Participants
|
169 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
86 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Native Alaskan/Inuit
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: African
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: African-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: African-Caribbean
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Asian (other than Chinese and Japanese)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Applicable
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
96 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Stratification: Prior taxane (This stratification information iis based on CRF data).
Prior taxane: Yes
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Stratification: Prior taxane (This stratification information iis based on CRF data).
Prior taxane: No
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Stratification: Hormone receptor status (This stratification information iis based on CRF data).
Hormone receptor status Positive [ER+ and/or PgR+]
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Stratification: Hormone receptor status (This stratification information iis based on CRF data).
Hormone receptor status Negative [ER-/PgR-]
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Stratification: Prior chemotherapy (This stratification information iis based on CRF data).
Prior chemotherapy: Yes
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
|
Stratification: Prior chemotherapy (This stratification information iis based on CRF data).
Prior chemotherapy: No
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
78 Participants
n=8 Participants
|
NA Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participantPopulation: Safety population (all participants who received at least one dose)
DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval \> 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.
Outcome measures
| Measure |
AZD8931 160 mg bd
n=6 Participants
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 120 mg bd
n=2 Participants
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 80 mg bd
n=6 Participants
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40 mg bd
n=6 Participants
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
|---|---|---|---|---|
|
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
Total
|
2 Number of Dose Limiting Toxicities
|
1 Number of Dose Limiting Toxicities
|
2 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
|
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
Eye disorders: Keratitis
|
1 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
|
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
Eye disorders: Photophobia
|
1 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
|
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
Gastrointestinal disorders: Diarrhoea
|
1 Number of Dose Limiting Toxicities
|
1 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
|
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
Gastrointestinal disorders: Oesophagitis
|
0 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
1 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
|
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
Infections and infestations: Rash pustular
|
0 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
1 Number of Dose Limiting Toxicities
|
0 Number of Dose Limiting Toxicities
|
PRIMARY outcome
Timeframe: Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012Population: Full Analysis Set
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)
Outcome measures
| Measure |
AZD8931 160 mg bd
n=69 events
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 120 mg bd
n=68 events
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
|---|---|---|---|---|
|
Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
|
8.7 Months
Interval 4.2 to 12.9
|
9.1 Months
Interval 3.4 to 14.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012Population: Evaluable for response set (EFR set is all FAS patients with measureable disease at baseline)
The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or \>1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))
Outcome measures
| Measure |
AZD8931 160 mg bd
n=88 Participants
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 120 mg bd
n=85 Participants
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
|---|---|---|---|---|
|
Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
Total
|
52 Participants
Interval 4.2 to 12.9
|
35 Participants
Interval 3.4 to 14.8
|
—
|
—
|
|
Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
Complete Response
|
11 Participants
|
6 Participants
|
—
|
—
|
|
Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
Partial Response
|
41 Participants
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012Population: Full Analysis Set
The time from the date of randomization until the date of death due to any cause.
Outcome measures
| Measure |
AZD8931 160 mg bd
n=28 events
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 120 mg bd
n=24 events
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
|---|---|---|---|---|
|
Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
|
NA Months
Interval 13.1 to
Median and the upper limit of the inter-quartile range for both treatment groups are not calculable due to an insufficient number of events
|
NA Months
Interval 14.1 to
Median and the upper limit of the inter-quartile range for both treatment groups are not calculable due to an insufficient number of events
|
—
|
—
|
Adverse Events
AZD8931 40 mg bd
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD8931 80 mg bd
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD8931 120 mg bd
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
AZD8931 160 mg bd
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD8931 40MG bd + Paclitaxel
Serious events: 24 serious events
Other events: 93 other events
Deaths: 0 deaths
Placebo + Paclitaxel
Serious events: 14 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD8931 40 mg bd
n=6 participants at risk
|
AZD8931 80 mg bd
n=6 participants at risk
|
AZD8931 120 mg bd
n=2 participants at risk
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 160 mg bd
n=6 participants at risk
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40MG bd + Paclitaxel
n=94 participants at risk
|
Placebo + Paclitaxel
n=95 participants at risk
|
|---|---|---|---|---|---|---|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
KERATITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
PLEURAL INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
HYDROTHORAX
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CATHETER SITE INFLAMMATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
PYREXIA
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
PUBIS FRACTURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
EJECTION FRACTION DECREASED
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
VERTEBROBASILAR INSUFFICIENCY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
VOCAL CORD PARALYSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
BREAST FIBROSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN NECROSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
Other adverse events
| Measure |
AZD8931 40 mg bd
n=6 participants at risk
|
AZD8931 80 mg bd
n=6 participants at risk
|
AZD8931 120 mg bd
n=2 participants at risk
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 160 mg bd
n=6 participants at risk
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
|
AZD8931 40MG bd + Paclitaxel
n=94 participants at risk
|
Placebo + Paclitaxel
n=95 participants at risk
|
|---|---|---|---|---|---|---|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
XEROPHTHALMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
APATHY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
MADAROSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
FATIGUE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
26.6%
25/94 • Number of events 40 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
26.3%
25/95 • Number of events 29 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
12.8%
12/94 • Number of events 19 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.8%
16/95 • Number of events 25 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
24.5%
23/94 • Number of events 34 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
10.5%
10/95 • Number of events 14 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
GRANULOCYTOPENIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 27 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
14.9%
14/94 • Number of events 42 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
41.1%
39/95 • Number of events 86 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Ear and labyrinth disorders
EAR PAIN
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Endocrine disorders
ADDISON'S DISEASE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
ASTHENOPIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
CATARACT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
CONJUNCTIVAL DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
DRY EYE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
8.5%
8/94 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
ERYTHEMA OF EYELID
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EXOPHTHALMOS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EXTRAOCULAR MUSCLE PARESIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EYE DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EYE HAEMORRHAGE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EYE PRURITUS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
KERATITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
MACULAR DEGENERATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
MYOPIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
OCULAR TOXICITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
PUNCTATE KERATITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
SCLERAL HYPERAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
8.5%
8/94 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
12.6%
12/95 • Number of events 17 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
66.7%
4/6 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.0%
15/94 • Number of events 20 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/95 • Number of events 11 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ANAL INFLAMMATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ANAL PRURITUS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
CHAPPED LIPS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
CHEILITIS
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
20.2%
19/94 • Number of events 25 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
24.2%
23/95 • Number of events 29 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
DIARRHOEA
|
83.3%
5/6 • Number of events 12 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
100.0%
6/6 • Number of events 25 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
100.0%
2/2 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
83.3%
5/6 • Number of events 15 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
83.0%
78/94 • Number of events 247 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
34.7%
33/95 • Number of events 65 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
DRY MOUTH
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
17.0%
16/94 • Number of events 19 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
9.5%
9/95 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GASTRIC DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GINGIVITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GLOSSITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
INTESTINAL POLYP
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
LIP DRY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
LIP PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
MUCOUS STOOLS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
NAUSEA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
41.5%
39/94 • Number of events 69 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
31.6%
30/95 • Number of events 39 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
OESOPHAGEAL PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ORAL DYSAESTHESIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ORAL MUCOSAL BLISTERING
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
ORAL TOXICITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
PERIANAL ERYTHEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
RECTAL FISSURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
STOMATITIS
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
21.3%
20/94 • Number of events 26 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
25.5%
24/94 • Number of events 43 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
14.7%
14/95 • Number of events 27 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
ASTHENIA
|
83.3%
5/6 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
100.0%
6/6 • Number of events 11 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
100.0%
2/2 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
83.3%
5/6 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
26.6%
25/94 • Number of events 30 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
12.6%
12/95 • Number of events 16 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CATHETER SITE ERYTHEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CATHETER SITE HAEMATOMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CATHETER SITE INFLAMMATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CATHETER SITE PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CHEST PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
CHILLS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
FEELING COLD
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
INFUSION SITE DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
IRRITABILITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
MALAISE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
MUCOSAL DRYNESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
22.3%
21/94 • Number of events 35 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
9.5%
9/95 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
NODULE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
OEDEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
OEDEMA PERIPHERAL
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
10.6%
10/94 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.6%
11/95 • Number of events 18 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
9.6%
9/94 • Number of events 16 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 17 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
PYREXIA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.6%
11/95 • Number of events 11 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
SPINAL PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
General disorders
XEROSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Hepatobiliary disorders
GALLBLADDER PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
ABSCESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
CANDIDIASIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
CONJUNCTIVITIS BACTERIAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
CONJUNCTIVITIS INFECTIVE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
CYSTITIS
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
9.6%
9/94 • Number of events 11 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
DERMATOPHYTOSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
HORDEOLUM
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
LOCALISED INFECTION
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
NAIL BED INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
9.5%
9/95 • Number of events 12 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
ORAL PUSTULE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
25.5%
24/94 • Number of events 30 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
PHARYNGOTONSILLITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
RASH PUSTULAR
|
50.0%
3/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
14.9%
14/94 • Number of events 18 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
6.3%
6/95 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
TRACHEITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.7%
11/94 • Number of events 11 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.6%
11/95 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
20.2%
19/94 • Number of events 29 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
13.7%
13/95 • Number of events 22 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
VULVITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
ESCHAR
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
RECALL PHENOMENON
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
SKIN INJURY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
BLOOD CREATININE INCREASED
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
CAPILLARY FRAGILITY TEST
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
ELECTROCARDIOGRAM CHANGE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
PULMONARY PHYSICAL EXAMINATION ABNORMAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
URINE COLOUR ABNORMAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
8.5%
8/94 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 11 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
14.9%
14/94 • Number of events 25 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
20.0%
19/95 • Number of events 26 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
13.8%
13/94 • Number of events 20 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.8%
16/95 • Number of events 30 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
LIMB DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CONTRACTURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE RIGIDITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
8.5%
8/94 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/95 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
6.4%
6/94 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.6%
11/95 • Number of events 14 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
6.4%
6/94 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
9.5%
9/95 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Musculoskeletal and connective tissue disorders
SENSATION OF HEAVINESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
AGEUSIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
ANOSMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
APHASIA
|
16.7%
1/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
APHONIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
DIZZINESS
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 10 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/95 • Number of events 10 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
DYSAESTHESIA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
DYSARTHRIA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
9.6%
9/94 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
FACIAL NEURALGIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
13.8%
13/94 • Number of events 21 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.8%
16/95 • Number of events 18 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
HYPOGEUSIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
HYPOKINESIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
HYPOSMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
6.4%
6/94 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
MIGRAINE WITH AURA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
MOTOR DYSFUNCTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
29.8%
28/94 • Number of events 34 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
26.3%
25/95 • Number of events 27 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
13.8%
13/94 • Number of events 18 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
20.0%
19/95 • Number of events 22 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.7%
11/94 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.6%
11/95 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
AFFECT LABILITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
6.4%
6/94 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.6%
11/95 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
BRADYPHRENIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
12.8%
12/94 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
14.7%
14/95 • Number of events 14 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
MOOD ALTERED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
NERVOUSNESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
BLADDER PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
CYSTITIS HAEMORRHAGIC
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
10.6%
10/94 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
PYURIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
BREAST DISCHARGE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
BREAST ENGORGEMENT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
BREAST HAEMORRHAGE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
BREAST INFLAMMATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
GENITAL DISCHARGE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
GENITAL RASH
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
VAGINAL INFLAMMATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
VULVAL ULCERATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
VULVOVAGINAL BURNING SENSATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPNEUMOPATHY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
2/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
12.8%
12/94 • Number of events 14 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
20.0%
19/95 • Number of events 26 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
50.0%
3/6 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 10 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
8.4%
8/95 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
20.2%
19/94 • Number of events 21 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
11.6%
11/95 • Number of events 12 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
HYPEROXIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL MUCOSAL DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL OBSTRUCTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL DISCOMFORT
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
RHINALGIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER AIRWAY OBSTRUCTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
47.9%
45/94 • Number of events 45 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.5%
48/95 • Number of events 49 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
22.3%
21/94 • Number of events 40 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
HEAT RASH
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLOURATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
8.4%
8/95 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
NAIL DYSTROPHY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
NAIL PIGMENTATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
ONYCHOMADESIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
19.1%
18/94 • Number of events 19 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
6.3%
6/95 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
RASH
|
50.0%
3/6 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
83.3%
5/6 • Number of events 19 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
66.7%
4/6 • Number of events 15 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
62.8%
59/94 • Number of events 136 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
21.1%
20/95 • Number of events 26 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN CHAPPED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN PLAQUE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN STRIAE
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
SWELLING FACE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
TELANGIECTASIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 11 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
HYPERAEMIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/94 • Number of events 24 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
LYMPHOEDEMA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
6.3%
6/95 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/95 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.3%
4/94 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/95 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
TINEA INFECTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Infections and infestations
URETERITIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
2.1%
2/94 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
1/2 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
22.3%
21/94 • Number of events 27 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
15.8%
15/95 • Number of events 17 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Nervous system disorders
NEUROTOXICITY
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
66.7%
4/6 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
10.5%
10/95 • Number of events 19 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
INCONTINENCE
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Renal and urinary disorders
LEUKOCYTURIA
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
5.3%
5/94 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
4.2%
4/95 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
3.2%
3/94 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DERMATOSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/94 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/95 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
50.0%
3/6 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
34.0%
32/94 • Number of events 36 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
7.4%
7/95 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
|
Vascular disorders
VARICOSE VEIN
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/2 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/6 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
0.00%
0/94 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
1.1%
1/95 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60